Duns Number:830016148
Device Description: CM5-200BNS BULK NON STERILE TIPS
Catalog Number
CM5-200BNS
Brand Name
Curos Tips™
Version/Model Number
CM5-200BNS
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
Yes
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LKB
Product Code Name
Pad, alcohol, device disinfectant
Public Device Record Key
ba026838-39cf-4e49-8c28-df13cec101fa
Public Version Date
September 09, 2020
Public Version Number
4
DI Record Publish Date
October 13, 2016
Package DI Number
50707387773866
Quantity per Package
10
Contains DI Package
30707387773862
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 274 |
2 | A medical device with a moderate to high risk that requires special controls. | 444 |
U | Unclassified | 7 |